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Regulatory Approval, Pricing, and Reimbursement

Life sciences executives face a myriad of obstacles relating to these issues. The following articles and presentations showcase tips useful to navigate these issues.

Dividing the Intellectual Property Pie in the Life Sciences Industry: Issues to Consider Prior to Granting Licenses to Various Collaboration Partners, New Jersey Law Journal
Morgan Lewis partner David Glazer co-authored this article on issues to consider prior to granting licenses to various collaboration partners.
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Expanding the Pharma/Biotech Business in the United States: Regulatory and Competition Issues (Chapter 15), Emerging Life Sciences Companies Deskbook – Spring 2008 (Morgan Lewis)
This chapter outlines multiple issues, concerns, and opportunities for expanding in the United States.
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FDA Due Diligence for Pharmaceuticals and Biologics Products (Chapter 21), Emerging Life Sciences Companies Deskbook – Spring 2008 (Morgan Lewis)
This chapter highlights the due diligence needed on FDA items when looking to partner with another company through an in-license transaction or collaboration agreement, or when seeking to acquire a product outright from another company.
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Licensing in the Pharmaceutical Industry: Strategies and Questions Regarding Antitrust Premerger Notification (Chapter 24), Emerging Life Sciences Companies Deskbook – Spring 2008 (Morgan Lewis)
This chapter provides general guidance with respect to the HSR Act implications of licensing arrangements in the pharmaceutical industry context.
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Medicare Act of 2003 Provides New Competitive Landscape for the Pharmaceutical Industry (Chapter 20), Emerging Life Sciences Companies Deskbook – Spring 2008 (Morgan Lewis)
This chapter focuses on the changes seen from the Medicare Act of 2003.
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Medicare Coverage of Drugs and Devices Under Medicare Parts A and B (Chapter 17), Emerging Life Sciences Companies Deskbook – Spring 2008 (Morgan Lewis)
This chapter addresses the general coverage requirements for drugs and devices under Medicare Parts A and B.
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Medicare Reimbursement for Drugs and Devices (Chapter 18), Emerging Life Sciences Companies Deskbook – Spring 2008 (Morgan Lewis)
This chapter outlines the process for receiving reimbursement for drugs and medical devices.
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Navigating the FDA: Moving from Product Concept Through Agency Review and Clearance/Approval, Pittsburgh Life Sciences Greenhouse Spring Training Series (April 25, 2008)
Morgan Lewis partner Beth Bierman and provides an overview of the FDA review process through case studies.
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Risk Management for Drugs and Biologics in the United States (Chapter 16), Emerging Life Sciences Companies Deskbook – Spring 2008 (Morgan Lewis)
This chapter focuses on the demands of a new, better-integrated, risk-management strategy by pharmaceutical companies.
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What Medical Technology Companies Should Know About Program Integrity Issues Arising from Reimbursement and Marketing (Chapter 19), Emerging Life Sciences Companies Deskbook – Spring 2008 (Morgan Lewis)
Emerging companies focused on drugs, devices, and related technology should be aware of the potential for government and private enforcement action regarding alleged fraudulent reimbursement and marketing activities and false claims. This outline briefly summarizes the principal laws in this area, theories of prosecution, sources of guidance, and suggested areas of focus to reduce the potential for such claims.
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